Apparatus and method for repairing vaginal reconstruction

ABSTRACT

Described are pelvic implants for treating vaginal prolapse, systems including the described pelvic implants, and methods of using the described implants and systems.

PRIORITY

The present non-provisional patent Application claims benefit from U.S.Provisional Patent Application having Ser. No. 61/036,688, filed on Mar.14, 2008, by Rane et al., and titled APPARATUS AND METHOD FOR REPAIRINGVAGINAL RECONSTRUCTION, wherein the entirety of said provisional patentapplication is incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates to vaginal prolapse repair and moreparticularly to transvaginal prolapse repair.

BACKGROUND

Anterior vaginal prolapse repairs have historically had recurrence ratesof around thirty percent. This is because traditional surgery usesdevitalized tissues and paravaginal defects are very difficult tocorrect transvaginally. Laparoscopic paravaginal defect correction istechnically very difficult and there is no data looking at its efficacy.The use of “mesh” for prolapse repair shows greater efficacy in arandomized trial by Sand et al. but does not address total anteriorvaginal reconstruction and certainly not paravaginal defect correction.

SUMMARY

The invention relates to treatments of vaginal prolapse of the typesreferred to as anterior vaginal prolapse, cystocele, lateral defects,and paravaginal defects. According to embodiments of the invention, meshimplants are provided and placed in a pelvic region to support vaginaltissue, bladder tissue, or both, either directly or by supporting tissuethat would otherwise support the bladder or vaginal tissue.

A paravaginal defect is a defect of tissue that supports the bladder ina position superior to the vagina. This type of defect can cause thebladder to fall into the vagina and result in vaginal prolapse,including anterior vaginal prolapse such as cystocele, or a lateraldefect. An example of a paravaginal defect is a defect in thehammock-type tissue (e.g., pubocervical fascia) that supports thebladder, such as a tear or detachment of the tissue at a “tree end” ofthe tissue (e.g., the portion of the fascia away from the vaginaltissue, near the arcus tendineus) rather than a tear in the sheet(midline defect). A specific example of a paravaginal defect can be tornpubocervical fascia along or near an arcus tendineus. The defect may beunilateral or bilateral, either way resulting in a cystocoele. A lateraldefect (e.g., paravaginal defect) can allow bladder tissue to becomeunsupported and contact vaginal tissue, resulting in vaginal prolapse,e.g., anterior vaginal prolapse or cystocele. Implants and methods ofthe present description can treat such conditions by supporting orreplacing one or more of vaginal tissue, bladder tissue, or vaginalsupport tissue or bladder support tissue (e.g., pubocervical fascia).

As used herein, the vaginal sulcus is the lateral depth of vagina in theanterior compartment. The vaginal sulcus is usually between 2 and 5centimeters deep and increases in depth as the vagina extends in aposterior direction.

Advantages of the present invention include reconstructing the arcustendineus with prolene, thereby giving strength. Another advantageincludes providing more anatomical repair. The procedure is a minimallyinvasive technique when compared with abdominal paravaginal repair.

In one aspect, the invention relates to an implantable device useful fortreating vaginal prolapse including a paravaginal defect. The deviceincludes a mesh support portion and multiple mesh extension portions,the support portion is capable of supporting a bladder. Each extensionportion is capable of extending to tissue of an obturator foramen whilethe support portion supports the bladder.

In another aspect, the invention relates to a system for treatingvaginal prolapse. The system includes two implants. Each implantincludes a mesh support portion and two mesh extension portions. Foreach implant the support portion is capable of contacting vaginal sulcustissue while the two extension portions extend to tissue of an obturatorforamen.

In another aspect, the invention relates to a method of treatingcystocele related to a lateral vaginal defect. The method includes:providing an implant as described herein; making an upper vaginalmidline incision; passing the implant through the vaginal incision;placing the mesh support portion in a position superior to vaginaltissue, to support a bladder; making a superior left external incisionat an inner thigh adjacent to a left obturator foramen, preparing atissue path between the superior left external incision and the lateralvaginal tissue on a left side of the vagina, passing an extensionportion through the tissue path between the superior left externalincision and the lateral vaginal tissue on the left side of the vagina;making an inferior left external incision at an inner thigh adjacent toa left obturator foramen, preparing a tissue path between the inferiorleft external incision and the lateral vaginal tissue on a left side ofthe vagina, passing an extension portion through the tissue path betweenthe inferior left external incision and the lateral vaginal tissue onthe left side of the vagina; making a superior right external incisionat an inner thigh adjacent to a right obturator foramen, preparing atissue path between the superior right external incision and the lateralvaginal tissue on a right side of the vagina, passing an extensionportion through the tissue path between the superior right externalincision and the lateral vaginal tissue on the right side of the vagina;making an inferior right external incision at an inner thigh adjacent toa right obturator foramen, preparing a tissue path between the inferiorright external incision and the lateral vaginal tissue on a right sideof the vagina, and passing an extension portion through the tissue pathbetween the inferior right external incision and the lateral vaginaltissue on the right side of the vagina.

In another aspect, the invention relates to a method of treatingcystocele, including treating a lateral vaginal defect. The methodincludes: providing a system of implants as described; making an uppervaginal midline incision; passing a first implant of the system throughthe vaginal incision; placing a mesh support portion of the firstimplant in contact with lateral vaginal tissue on a left side of thevagina; making a superior left external incision at an inner thighadjacent to a left obturator foramen, preparing a tissue path betweenthe superior left external incision and the lateral vaginal tissue on aleft side of the vagina, passing a first extension portion of the firstimplant through the tissue path between the superior left externalincision and the lateral vaginal tissue on the left side of the vagina;making an inferior left external incision at an inner thigh adjacent toa left obturator foramen, preparing a tissue path between the inferiorleft external incision and the lateral vaginal tissue on a left side ofthe vagina, passing a second extension portion of the first implantthrough the tissue path between the inferior left external incision andthe lateral vaginal tissue on the left side of the vagina; passing asecond implant through the vaginal incision; placing a mesh supportportion of the second implant in contact with lateral vaginal tissue ona right side of the vagina; making a superior right external incision atan inner thigh adjacent to a right obturator foramen, preparing a tissuepath between the superior right external incision and the lateralvaginal tissue on a right side of the vagina, passing a first extensionportion of the second implant through the tissue path between thesuperior right external incision and the lateral vaginal tissue on theright side of the vagina; making an inferior right external incision atan inner thigh adjacent to a right obturator foramen, preparing a tissuepath between the inferior right external incision and the lateralvaginal tissue on a right side of the vagina, and passing a secondextension portion of the second implant through the tissue path betweenthe inferior right external incision and the lateral vaginal tissue onthe right side of the vagina.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a perspective view of an embodiment of an implant asdescribed, at least partially implanted in an illustrated pelvis.

FIGS. 1B-1E are various configurations of implants as described.

FIG. 2 illustrates a system or kit as described, including two implants.

FIGS. 3A and 3B illustrate examples of needles useful according tomethods described herein.

FIG. 4 is a perspective view of an embodiment of a system of implants asdescribed.

DETAILED DESCRIPTION

The inventive concept utilizes the transobturator approach (usedsuccessfully by AMS for suburethral slings) and has two designsconcepts. One design or embodiment is the TARS or TAWS (Total anteriorvaginal reconstruction system, or Total Anterior Wall Shelf) (see FIG.1A). The other design or embodiment is the PARS (Para vaginal Anteriorvaginal reconstruction) see FIG. 4.

An implant can generally include a support portion that contacts tissueto be supported, and two or more opposing extension portions that extendaway from the support portion. The terms “support portion” and“extension portion” can be used specifically or generally to denoteprecise or general portions of an implant. When an implant has a uniformshape from end to end, as does a simple mesh strip, the end portionswill not necessarily exhibit a distinct boundary relative to the supportportion.

Exemplary implants may be in the form of a continuous mesh tape thatincludes a support portion located at the center of the mesh, and twoend portions, one end portion extending in each direction from thecentral support portion. Other implants can include a support portionhaving larger dimensions relative to the extension portions, withmultiple (e.g., two or four) elongate extension portions extending fromthe support portion.

In one embodiment, a size and shape of an implant support portion can befor use to contact and support vaginal tissue, nearby bladder tissue, orboth, to treat prolapse, specifically anterior defects, lateral defects,and cystocele. These exemplary implants may be useful in the TARS andTAWS procedures. For example, a support portion may be sized to contactand support a bladder superior to prolapsed vaginal tissue.Functionally, such a support portion may be designed to act as supportfor the bladder, as a replacement to, or reinforcement of, thehammock-type tissue that naturally supports the bladder, includingpubocervical fascia. The support portion can be placed to contactbladder tissue and tissue supportive of the bladder, includingpubocervical fascia. The support portion can be attached to the bladdersupport tissue (e.g., pubocervical fascia) and may extend to be near(within 1 centimeter from) or in contact with the arcus tendineus. Suchembodiments of support portions can include curved or circular edges andmay be circular in shape (meaning circular, oblong, oval, orapproximately circular with multiple obtuse angles). Alternate supportportions may be square, rectangular, or rectangular with rounded ends,such as rectangular with rounded anterior and posterior ends. A supportportion may be of a size to extend from one lateral side of a pelvicregion, below a bladder, and across to the other lateral side of thepelvic region, e.g., from near or in contact with one arcus tendineus,across the pelvic region and below a bladder, to a position that is nearor in contact with an opposing arcus tendineus. The mesh support portioncan form new support tissue for the bladder (e.g., a hammock) over whichthe bladder is suspended.

Other implant embodiments, e.g., useful in the PARS and PAWSembodiments, can include a support portion that can be connected tolateral vaginal tissue (vaginal sulcus) on one side of a vagina. Two ofthese implants can be used in combination, one being implanted on eachof a left side and a right side of a vagina, to support both a lateralleft side and a lateral right side tissue of a vagina, to treatparavaginal, lateral, and anterior defects and cystocele. For example,such a support portion can be in the form of an elongate strip having alength in the range from about 4 to about 5 centimeters and width in therange from about 0.5 to about 1.3 centimeters.

Optionally and preferably an implant can include one or more appurtenantfeatures including a tensioning device (or “tensioning member”) such asa suture or a sheath, and a connector or a dilating connector (e.g.,“dilator,” suture, or the like) that removably or securely (e.g.,permanently) engages a tip of a needle of an implantation tool.

In various embodiments an implant may be a one piece mesh strip with thesupport portion substantially continuous with (i.e., integral with) endportions, also optionally including a plastic sheath enclosing the meshstrip, an optional tensioning suture running along all or a portion ofthe length of the mesh strip, and one or two connectors, sutures, ordilators, one at the end of each extension portion. Yet a furtherfeature can be one or more sutures or other attachment mechanismslocated and attached at an end of the implant or along a length of theimplant, for example extending from a support portion or an extensionportion.

An implant can be placed within a tissue path by assistance of aninsertion tool. Examples of insertions tool that include an elongateneedle useful to prepare one or more of the tissue paths describedherein, include those described at United States Patent Applications2005/0245787 (Ser. No. 10/834,943), 2007/0068538 (Ser. No. 11/518,932),2005/0143618 (Ser. No. 11/064,875), and 2009-0023978 (Ser. No.12/229,655), the entireties of these documents being incorporated hereinby reference. Such tools generally include a handle and an elongateneedle portion that is curved in two or three dimensions. The needle canbe used to create a tissue path extending from an external incision to aregion of vaginal tissue near a vaginal (e.g., mid-line) incision, andalso to pull or push an implant or a portion thereof (e.g., extensionportion) through the tissue path.

Referring to the example embodiment of TARS and TAWS illustrated atFIGS. 1A through 1E, embodiments of these implant can have varied shapesand configurations. In at least one embodiment of each there can be acentral portion (or “support portion”) capable of supporting ananatomical structure such as the bladder. A number of arms (or“extension portions”) useful to secure the implant in a patient canextend away from the support portion.

Referring specifically to FIG. 1A, this illustration shows a pelvicregion including pelvic bone, pubic symphasis 20, right and leftobturator foramen 24, bladder 22, and obturator vessels and nerves 26.Implant 10 includes mesh support portion 14 positioned above a vagina(not shown) to support the bladder. The implant can be positioned in amanner to support bladder 22 and treat cystocele, e.g., due to alateral, e.g., paravaginal defect. The positioning can include placingsupport portion 14 below bladder 22, optionally with edges 13 locatednear or in contact with tissue of opposing arcus tendineus (not shown),e.g., each edge 13 can be located within 1 centimeter of a right or leftarcus tendineus, or in contact with the arcus tendineus.

Still referring to FIG. 1, four longitudinal extension portions 12extend away from support portion 14. Each extension portion 12 extendswithin a tissue path leading from a region of the vaginal tissue to anobturator foramen. (Two extension portions 12 are shown in implantedpositions through an obturator foramen, and two others are shownpartially implanted.) Two superior (anterior) arms (alternatelyconsidered, an anterior segment or edge of the support portion) can beplaced at or just below the bladder neck and extend to a superiorincision. Two inferior (posterior) arms (alternately considered, aposterior segment or edge of the support portion) can be placed 1.5centimeters proximal to the ischial spine. Each extension portion can beextended through an obturator foramen at a separate incision, onesuperior and one inferior, and then continue further through an externalincision (not shown), including one superior external incision and oneinferior external incision per side of the patient. An example of asuperior external incision may be placed approximately 0.5 centimetersmedial to a geniot crural fold at the level of the clitoris below anadductor longus tendon. An example of an inferior external incision maybe placed approximately 2 centimeters lateral to and 3 centimeters belowthe superior incision; this point should correspond to the lowermostportion of the obturator membrane directly above the ischialtuberosity—if by palpation this point is askew then the palpatory pointcan be used for precise incision inferiorly.

FIG. 1B shows a specific design of a mesh implant useful according tothe TARS embodiment, e.g., as illustrated at FIG. 1A. Implant 30includes rectangular or square support portion 32 and four elongateextension portions 34, each extending away from a corner of supportportion 32. Length dimension L2, the length of the total implantincluding support portion 32 and two opposing extension portions 34, maybe from 15 to 20 centimeters. Lengths L1 of each extension portion 34may be, e.g., from 4 to 6 centimeters. Width W2 of support portion 32can be, e.g., from 3 to 6 centimeters. Width W1 of each extensionportion 32 can be from 0.5 to 1.3 centimeter.

FIG. 1C shows another specific design of a mesh implant useful accordingto the TARS embodiment, e.g., as illustrated at FIG. 1A. Implant 40includes support portion 42 and four elongate extension portions 44,each extending away from a corner of support portion 42. Support portion42 is rectangular with rounded anterior and posterior ends. Lengthdimension L4 may be from 15 to 20 centimeters. Lengths L3 of eachextension portion 44 may be, e.g., from 4 to 6 centimeters. Width W4 ofsupport portion 42, including the two rounded ends can be, e.g., from 3to 8 centimeters. Width W3 of each extension portion 4 can be from 0.5to 1.3 centimeter.

FIG. 1D shows another specific design of a mesh implant useful accordingto the TARS embodiment, e.g., as illustrated at FIG. 1A. Implant 45includes support portion 46 and four elongate extension portions 48.Each extension portion extends away from an edge (e.g., corner) ofsupport portion 46 in a direction perpendicular to the edge of thecircular support portion. Alternately, other angles may be useful; forexample extension portions 48 of implant 45 may be arranged similarly toextension portions 44 of implant 40, sets of extension portionsextending from the support portion in parallel and opposing directions.Support portion 46 is circular and may be oval or oblong. Lengthdimension L5 may be from 15 to 20 centimeters. Lengths L6 of eachextension portion 48 may be, e.g., from 4 to 6 centimeters. Width(diameter) W6 of support portion 46 can be, e.g., from 3 to 8centimeters. Width W5 of each extension portion 48 can be from 0.5 to1.3 centimeter.

FIG. 1E shows another specific design of a mesh implant useful accordingto the TARS embodiment, e.g., as illustrated at FIG. 1A. Implant 49includes support portion 50 and two elongate extension portions 52. Eachextension portion extends away from an edge of support portion 50 in adirection perpendicular to the edge, and opposite and parallel with theopposing extension portion. Support portion 50 is square but may berectangular, trapezoidal, etc. Length dimension L8 may be from 15 to 20centimeters. Lengths L9 of each extension portion 52 may be, e.g., from4 to 6 centimeters. Width W7 of support portion 50 can be, e.g., from 3to 6 centimeters. Length L9 of support portion 50 can be, e.g., from 3to 6 centimeters. Width W8 of each extension portion 52 can be from 0.5to 1.3 centimeter.

Referring to an embodiment of a system of implants useful in the PARSmethod, illustrated in FIG. 2, each of a pair of implants can be agenerally elongate member having a pair of ends, i.e., mesh strips ofsubstantially uniform length and construction. Implants 60 and 62 eachinclude a mesh support portion (P_(S)) (preferably from 4 to 6centimeters in length and from 0.5 to 1.3 centimeters wide) and twoextension portions (P_(E)), one on either side of the support portion(also preferably from 4 to 6 centimeters in length and from 0.5 to 1.3centimeters wide). A guide suture or other guide device can be attachedto each end of the mesh strip; as illustrated, sutures 64 are attachedat each end of implants 60 and 62. The guide sutures on the ends of theelongate body can be used to pull the elongate member through a tissuepath, e.g., by assistance using an insertion tool, optionally a twodimensional or a helical insertion tool. For example guide sutures 64can be attached to needles, illustrated in FIGS. 3A and 3B, which can beused to guide and pull the elongate member through the patient's tissue.

As particularly illustrated in FIG. 2, placement sutures or anchors canbe disposed on a portion of the elongate member between its ends, alongits length. As illustrated, three placement sutures 66 are located alongthe length of the implant and can be used to position or place theelongate member on an anatomical structure such as the vaginal sulcus,e.g., the sutures can be attached to vaginal tissue such as vaginalsulcus tissue.

Implant 62 of FIG. 2 includes an optional sheath 68, covering thesupport portion, placement sutures 66, and at least portions ofextension portions. The sheath can be a transparent plastic sheath orenvelope, for example, that can remain on the sheath during insertionand that can be removed after the position of the implant is adjusted asdesired.

Implants 60 and 62 can be made from any material such as a mesh materialand the placement sutures and guide sutures can be made from anymaterial such as the material used for vicryl sutures. As illustrated inFIG. 2, the elongate member can be enclosed by a plastic sheath orenvelope that aids in moving the elongate member through a patient'stissue. The sheath or envelope can be made of any material such asplastic or paper, optionally lubricated, and can preferably be a clearflexible plastic.

FIG. 4 illustrates a pelvic region including pelvic bone, pubicsymphasis 20, right and left obturator foramen 24, vaginal sulci 25,midline incision 27 in vaginal tissue, and obturator vessels and nerves26. Each implant 80 is a mesh strip that includes mesh support portion84, extension portions 82, and sutures 86. Each mesh support portion 84is attached to lateral vaginal tissue (sulcus) by sutures 86. Eachextension portion 82 extends within a tissue path leading from a regionof vaginal tissue to an obturator foramen. As illustrated, eachextension portion 82 further extends through the obturator foramen at aseparate incision (one incision for each extension portion 82), onesuperior and one inferior, and then continues further through anexternal incision (not shown), including one superior external incisionand one inferior external incision, per side of the patient.

Referring to FIGS. 3A and 3B, insertion tool 70 comprising needle 72 andhandle 74 is suitable for use in methods described herein. Handle 72 canbe any suitable handle known in the art or otherwise useful. U.S. Pat.No. 6,652,450, hereby incorporated by reference in its entirety,discloses several possible configurations. Needle 72 is generally curvedor arcuate, preferably in three dimensions, to form a helix asillustrated. The shape of needle 72 should facilitate and providecontrolled passage of needle 74 through tissue as required, e.g., toallow the tip to pass from an external incision at a labia or innergroin region of a patient, through an obturator foramen, and to a regionof vaginal tissue.

End or tip 76 of needle 72 can be configured to engage an end of animplant, such as a dilator, connector, suture, or mesh piece at an endof an implant. Many different configurations of such a system are knownand within the scope of the present invention. Several are disclosed inU.S. Pat. No. 6,652,450, which is incorporated by reference, as well asother patent documents identified herein. Tip 76 is generally notsharpened but may be tapered to afford easy passage through tissue whileproviding a blunt surface that avoids cutting sensitive tissue. It ispreferred that the diameter of needle 72 be small, to reduce tissuetrauma.

To perform a TARS or TAWS placement, the patient is placed in alithotomy position. The physician makes a mid-line vaginal incision anddissects equal to a typical central cystocele repair. External incisionsare then made near the obturator foramen, e.g., a superior externalincision and an inferior external incision, one on each side of thepatient. Using a two-or three-dimensionally curved needle, such as theone illustrated in FIGS. 3A and 3B, an end of the needle can be pushedthrough an external incision and through the obturator foramen to enterthe vagina through the vaginal incision, to meet and engage an extensionportion of the implant. A second needle (two-dimensionally orthree-dimensionally curved) can be used in a second incision through theobturator foramen. One of the needles can enter into a lower ⅓ of thevagina and the other needle can enter into a mid portion of the vagina.The arms (extension portions) of the implant can be attached to theneedles, which can be withdrawn through the obturator foramen. Anterior(superior) extension portions or an anterior edge or portion of theimplant can be placed under the base of the bladder or 1 cm inferior tothe base of the bladder or just below the bladder neck. Inferior(posterior) extension portions or a posterior edge or portion of theimplant can be placed at the vagina approximately 1 centimeter proximalto the ischial spine.

Exemplary steps of a method of placing an implant as illustrated at FIG.1, for treating a lateral vaginal defect (e.g., paravaginal defect) andrelated cystocele, can include the following features.

Providing an implant as described, having a support portion and fourextension portions.

Making an upper vaginal midline incision.

Passing the implant through the vaginal incision.

Placing the mesh support portion in a position superior to vaginaltissue, to support a bladder. The mesh support portion may extend belowthe bladder, optionally to opposing arcus tendineus of the patient,either to contact the arcus tendineus or to be within 1 centimeter ofthe arcus tendineus. The mesh support portion may optionally beattached, e.g., by suture, staple, or other securement mechanism, totissue such as pubocervical fascia, arcus tendineus, or both.

Making a superior left external incision at an inner thigh adjacent to aleft obturator foramen.

Preparing a tissue path between the superior left external incision andthe lateral vaginal tissue on a left side of the vagina, e.g., using ahelical needle.

Passing an extension portion through the tissue path between thesuperior left external incision and the lateral vaginal tissue on theleft side of the vagina.

Making an inferior left external incision at an inner thigh adjacent toa left obturator foramen.

Preparing a tissue path between the inferior left external incision andthe lateral vaginal tissue on a left side of the vagina, e.g., using ahelical needle.

Passing an extension portion through the tissue path between theinferior left external incision and the lateral vaginal tissue on theleft side of the vagina.

Making a superior right external incision at an inner thigh adjacent toa right obturator foramen,

Preparing a tissue path between the superior right external incision andthe lateral vaginal tissue on a right side of the vagina, e.g., using ahelical needle.

Passing an extension portion through the tissue path between thesuperior right external incision and the lateral vaginal tissue on theright side of the vagina.

Making an inferior right external incision at an inner thigh adjacent toa right obturator foramen,

Preparing a tissue path between the inferior right external incision andthe lateral vaginal tissue on a right side of the vagina, e.g., using ahelical needle.

And passing an extension portion through the tissue path between theinferior right external incision and the lateral vaginal tissue on theright side of the vagina.

To perform a PARS placement, a physician identifies a defect such asdisplacement cystocele with paravaginal defect. The physician can thenclearly identify the vaginal sulcus and ensure there is sufficienttissue to attach implant material on both sides if necessary. A surgicalmarker can be used if needed. A mid-line vaginal incision can be madeand routine para urethral dissection into the retropubic space isconducted. Next, a digital palpitation of posterior aspect of obturatorinternus is done. A physician should then palpate on the external skinof vulva where the mesh will pull through in 2 points (e.g., a superiorincision and an inferior incision as these are described herein). Themesh (support portion ) can then be attached to the vaginal sulcus withthe placement sutures. Additional placement sutures can be trimmed orattached if necessary.

An external incision can be made near the obturator foreman. Using aneedle such as the one illustrated in FIGS. 3A and 3B, its end can bepushed through the obturator foramen to enter the vagina through themidline incision. Repeat at a posterior-inferior site keeping clear ofthe obturator vessels. To ensure proper placement, the ends of theneedles can be guided using one or more digits of your hand within theretropubic space.

In one embodiment, the guide sutures can be attached to the needles andthe mesh (mesh strip implant) can be pulled through the obturatorforamen and external incision. While pulling the mesh placement shouldbe checked on both sides without removing the plastic sheath (ifpresent). Ensure that the midline vaginal incision can be closed withouttension. The vaginal incision is then closed and the midline fascia canbe repaired if necessary. The implant can then be adjusted. Lastly, theplastic envelope (if present) can be removed and the mesh implant can betrimmed flush with the skin. The mesh implant can be left unsutured orsutured.

Exemplary steps of a method of placing a system of implants asillustrated at FIG. 3, for treating a paravaginal defect and relatedcystocele, can include the following features.

Providing a system of implants as described herein, e.g., as illustratedat FIG. 3.

Making an upper vaginal midline incision.

Passing a first implant through the vaginal incision.

Placing a mesh support portion of the first implant in contact withlateral vaginal tissue (sulcus) on a left side of the vagina.

Making a superior left external incision at an inner thigh adjacent to aleft obturator foramen.

Preparing a tissue path between the superior left external incision andthe lateral vaginal tissue (sulcus) on a left side of the vagina,

Passing a superior extension portion of the first implant through thetissue path between the superior left external incision and the lateralvaginal tissue on the left side of the vagina.

Making an inferior left external incision at an inner thigh adjacent toa left obturator foramen.

Preparing a tissue path between the inferior left external incision andthe lateral vaginal tissue on a left side of the vagina,

Passing an inferior extension portion of the first implant through thetissue path between the inferior left external incision and the lateralvaginal tissue on the left side of the vagina.

Passing a second implant through the vaginal incision.

Placing a mesh support portion of the second implant in contact withlateral vaginal tissue (sulcus) on a right side of the vagina.

Making a superior right external incision at an inner thigh adjacent toa right obturator foramen.

Preparing a tissue path between the superior right external incision andthe lateral vaginal tissue on a right side of the vagina.

Passing a superior extension portion of the second implant through thetissue path between the superior right external incision and the lateralvaginal tissue on the right side of the vagina.

Making an inferior right external incision at an inner thigh adjacent toa right obturator foramen.

Preparing a tissue path between the inferior right external incision andthe lateral vaginal tissue on a right side of the vagina.

And passing an inferior extension portion of the second implant throughthe tissue path between the inferior right external incision and thelateral vaginal tissue on the right side of the vagina.

1. An implantable device useful for treating vaginal prolapse includinga paravaginal defect, the device comprising a mesh support portion andmultiple mesh extension portions, the support portion being capable ofsupporting a bladder, each extension portion being capable of extendingto tissue of an obturator foramen while the support portion supports thebladder.
 2. The device of claim 1 comprising exactly four extensionportions.
 3. The device of claim 2 wherein each portion has a lengthdimension in the range from 4 to 6 centimeters.
 4. The device of claim 1wherein the support portion is circular or rectangular with roundedanterior and posterior ends.
 5. A system for treating vaginal prolapsecomprising two implants, each implant comprising: a mesh support portionand two mesh extension portions, wherein for each implant the supportportion is capable of contacting vaginal sulcus tissue while the twoextension portions extend to tissue of an obturator foramen.
 6. Thesystem of claim 5 wherein the implant comprises a mesh strip, thesupport portion has a length of from 4 to 6 centimeters, the totallength of the mesh strip is from 15 to 20 centimeters, and the meshstrip is of substantially uniform width in the range from 0.5 to 1.3centimeters.
 7. The system of claim 5 comprising one or multiple helicalneedles.
 8. The system of claim 5 wherein the implant comprises twosutures, one suture connected at each opposing end of the implant. 9.The system of claim 5 wherein the implant comprises one or multiplesutures connected along a length of the implant.
 10. The system of claim5 wherein the implant comprises a sheath that covers the support portionand at least portions of the extension portions.
 11. A method oftreating cystocele related to a lateral vaginal defect, the methodcomprising providing an implant according to claim 1, making an uppervaginal midline incision, passing the implant through the vaginalincision, placing the mesh support portion in a position superior tovaginal tissue, to support a bladder, making a superior left externalincision at an inner thigh adjacent to a left obturator foramen,preparing a tissue path between the superior left external incision andthe lateral vaginal tissue on a left side of the vagina, passing anextension portion through the tissue path between the superior leftexternal incision and the lateral vaginal tissue on the left side of thevagina, making an inferior left external incision at an inner thighadjacent to a left obturator foramen, preparing a tissue path betweenthe inferior left external incision and the lateral vaginal tissue on aleft side of the vagina, passing an extension portion through the tissuepath between the inferior left external incision and the lateral vaginaltissue on the left side of the vagina, making a superior right externalincision at an inner thigh adjacent to a right obturator foramen,preparing a tissue path between the superior right external incision andthe lateral vaginal tissue on a right side of the vagina, passing anextension portion through the tissue path between the superior rightexternal incision and the lateral vaginal tissue on the right side ofthe vagina, making an inferior right external incision at an inner thighadjacent to a right obturator foramen, preparing a tissue path betweenthe inferior right external incision and the lateral vaginal tissue on aright side of the vagina, and passing an extension portion through thetissue path between the inferior right external incision and the lateralvaginal tissue on the right side of the vagina.
 12. The method of claim11 comprising attaching the support portion to pubocervical fascia andpositioning the support portion below a bladder and proximal to an arcustendineus.
 13. The method of claim 11 comprising: placing an anteriorsegment or edge of the support portion approximately below a bladderneck, and placing a posterior segment or edge of the support portionapproximately 1.5 centimeters proximal to an ischial spine.
 14. A methodof treating cystocele, including treating a lateral vaginal defect, themethod comprising providing a system according to claim 5, making anupper vaginal midline incision, passing a first implant through thevaginal incision, placing a mesh support portion of the first implant incontact with lateral vaginal tissue on a left side of the vagina makinga superior left external incision at an inner thigh adjacent to a leftobturator foramen, preparing a tissue path between the superior leftexternal incision and the lateral vaginal tissue on a left side of thevagina, passing a first extension portion of the first implant throughthe tissue path between the superior left external incision and thelateral vaginal tissue on the left side of the vagina, making aninferior left external incision at an inner thigh adjacent to a leftobturator foramen, preparing a tissue path between the inferior leftexternal incision and the lateral vaginal tissue on a left side of thevagina, passing a second extension portion of the first implant throughthe tissue path between the inferior left external incision and thelateral vaginal tissue on the left side of the vagina, passing a secondimplant through the vaginal incision, placing a mesh support portion ofthe second implant in contact with lateral vaginal tissue on a rightside of the vagina, making a superior right external incision at aninner thigh adjacent to a right obturator foramen, preparing a tissuepath between the superior right external incision and the lateralvaginal tissue on a right side of the vagina, passing a first extensionportion of the second implant through the tissue path between thesuperior right external incision and the lateral vaginal tissue on theright side of the vagina, making an inferior right external incision atan inner thigh adjacent to a right obturator foramen, preparing a tissuepath between the inferior right external incision and the lateralvaginal tissue on a right side of the vagina, and passing a secondextension portion of the second implant through the tissue path betweenthe inferior right external incision and the lateral vaginal tissue onthe right side of the vagina.